Metformin EP Impurity E (Hydrochloride Salt), PurCert

PurCert


Properties

Water Solubility Slightly soluble
Assay Purity >=98%
M pt. 148 - 151 °C
Form Solid

Safety Information

Hazard Statement(s) H302
Precautionary Statement  P264 - P270 - P301 + P312 - P501
GHS Pictogram
Signal word Warning
HS Code 29252990
Storage Temp. 2-8 °C
Storage Class 11 - Combustible Solids
UN Number NA

Description

Application
Metformin EP Impurity E is used as a pharmaceutical reference standard for the identification quantification and quality control of impurities in Metformin active pharmaceutical ingredients (APIs) and finished dosage forms in accordance with European Pharmacopoeia (EP) specifications.

Purpose
The purpose of Metformin EP Impurity E is to support pharmaceutical quality assurance by enabling accurate impurity profiling analytical method validation stability studies and regulatory compliance during the manufacture of Metformin.

General Description
Metformin EP Impurity E is a specified organic impurity described in the European Pharmacopoeia that is used as a certified analytical reference material for impurity testing and quality control and it is not intended for therapeutic or clinical use.